Numinus Wellness (NUMI.T) Highlights Key Milestones in MAPS-Sponsored Clinical Trial

$144.185M Market Capitalization

Numinus Wellness Inc. (NUMI.T) announced today that it has completed key steps in preparation for enrollment at the Company’s clinics participating in a “multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX). Aside from being a mouthful, the MAPPUSX clinical trial will be sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS).

“The recent approvals from Health Canada and the IRB, coupled with our clinics in Montreal and Vancouver already being regulatorily compliant, allow us to quickly conduct this phase of the research at these sites…,” said Dr. Joe Flanders, VP, Psychology, Numinus and therapist for the Montreal site of the trial.

Taking a Look at MAPS

Before we get into the details of Numinus’ latest news, let’s talk about MAPS. Founded in 1986, the Multidisciplinary Association for Psychedelic Studies (MAPS) is a 501(c)(3) non-profit organization. Put simply, a 501(c)(3) organization refers to religious, scientific, literary, educational, and charitable organizations registered in the Canadian Revenue Agency’s (CRA) list of charities. These organizations are automatically deemed a 501(c)(3) private foundation for tax exemption purposes.

With this in mind, MAPS specializes in research and education, with a focus on developing medical, legal, and cultural shifts surrounding psychedelics. Through research, education, and advocacy, the organization has dedicated the last 35 years to support the use of psychedelics and marijuana for mental and spiritual healing. In addition to Numinus’ MAPPUSX clinical trial, MAPS has sponsored MAPP1 and is currently sponsoring MAPP2.

MAPP1 & MAPP2 Clinical Trials

Studies MAPP1 and MAPP2 are randomized, double-blind, placebo-controlled, multi-site clinical trials that assess the safety and efficacy of MDMA-assisted therapy in 200-300 participants with severe posttraumatic stress disorder (PTSD) from any cause, aged 18 and older. MAPP1 and MAPP2 are the final phases of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD in conjunction with therapy.

“We are thrilled that our talented team of doctors and researchers at Numinus are helping pave the path forward to greater access to safe psychedelic-assisted psychotherapy with this study further evaluating the safety of MDMA-assisted therapy in treating severe PTSD…

This is an exciting next step in the MAPPUSX study, happening at our clinics in both British Columbia and Quebec, and we look forward to how this work supports expanded collaboration with MAPS in the future,” commented Payton Nyquvest, Founder and CEO, Numinus.

Referring back to Numinus MAPPUSX clinical study, the Company’s Canadian study sites, under the leadership of MAPS Public Benefit Corporation (MAPS PBC) as a study sponsor, have recently received regulatory authorization from Health Canada. Additionally, Numinus’ Canadian study sites have received ethical approval from an Institutional Review Board (IRB), and a Section 56 exemption from the Controlled Drug and Substance Act (CDSA).

For context, a section 56 exemption provides pharmacists with the authority to prescribe, sell, or provide a controlled substance to patients subject to the terms and conditions of this exemption. With this in mind, a section 56 exemption will allow the use of MDMA throughout the duration of Numinus’ MAPPUSX clinical trial.

Numinus will host the Canadian sites for MAPPUSX, managed through the Company’s two recently acquired clinics, allowing for quick completion of the Canadian segment of the MAPS-sponsored trial. Furthermore, the trial will be open to eligible participants who were previously enrolled in the placebo arm of the parent study, MAPP1, or who were not able to receive treatment due to COVID-19 restrictions.

A Problem with PTSD

Posttraumatic stress disorder (PTSD) is a psychiatric disorder that may occur in people who have experienced or witnessed a traumatic event, as defined by the American Psychiatric Association. In total, PTSD affects approximately 3.5% of adults in the United States (US) every year. Comparatively, the lifetime prevalence of PTSD ranges from 6.1% to 9.2% in national samples of the general adult population in the US and Canada.

That being said, an estimated one in 11 people will be diagnosed with PTSD in their lifetime. However, for a person to be diagnosed with PTSD, their symptoms must last for more than a month, cause significant distress, or create problems in their daily functioning. Symptoms of PTSD include:

Symptoms

intrusive thoughts such as distressing dreams, flashbacks, and involuntary memories
avoiding reminders of the traumatic experience including people, places, and activities, among others
alterations in cognition in mood; for example, feeling detached and estranged from others
changes in arousal and reactivity such as being irritable, reckless, or self-destructive

MDMA-Assisted Therapy as a Solution

During the duration of the MAPP1 clinical trial, participants underwent three 8-hour experimental sessions spaced four weeks apart with a single divided dose of 80 to 180 mg MDMA or placebo, in addition to three preparatory and nine integrative therapy sessions. At the primary endpoint, 67% of participants in the MDMA group no longer met diagnostic criteria for PTSD, compared with 32% of participants in the placebo group.

With this in mind, three sessions of MDMA-assisted therapy significantly reduced PTSD symptoms and functional impairment, compared to placebo. Furthermore, MDMA was well-tolerated, with participants reporting adverse events that were generally rated mild to moderate. These adverse events included muscle tightness, decreased appetite, nausea, hyperhidrosis, and feeling cold.

In Numinus’ official press release, the Company included the following note:

The safety of MDMA-assisted therapy is currently under investigation. It has not yet been approved by Health Canada or the U.S. Food and Drug Administration (FDA), does not work for everyone and carries risks even in therapeutic settings.

These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted therapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.

As a whole, the Psychedelics Drug Market is projected to reach USD$10.75 billion by 2027, expanding at a compound annual growth rate (CAGR) of 12.36%. This market is expected to grow relative to a growing acceptance of psychedelic drugs for treating mental disorders. If you’re interested in Numinus, keep an eye out for the Company’s upcoming Q1 2022 Financial Results on January 20, 2022.